Type 2 Diabetes MellitusPhase 1NCT06423872
A SAD Study of ZT002 Injection in Healthy Participants
A Phase 1 study testing ZT002 in people with Type 2 Diabetes Mellitus, run by Beijing QL Biopharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- ZT002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2023to 8 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fully understand the purpose, nature, methods, and potential adverse reactions of the experiment, voluntarily participate as a participant, comply with the requirements of this study, and sign an informed consent form.
- Healthy adults, age 18~45 years, both inclusive, at time of informed consent.
- Body Mass Index (BMI) between 19～27.0 kg/m2 both included. Male weight>55.0kg, famale weight>50.0kg.
- In good health, determined by no clinically significant findings from medical history, physical examination, vital signs measurements, anterior and lateral chest X-ray,12-lead ECG, and clinical laboratory evaluations(blood routine, blood biochemistry, coagulation function, and urine routine)at screening and before administration of study drug, as assessed by the Investigator.
- Female participants are required to abstain or use two effective contraceptive methods simultaneously from 1 month before screening to 6 months after the last dose. Male participants are required to abstain or use two effective contraceptive methods simultaneously from the first dose to 6 months after the last dose: male participants are required to undergo surgical sterilization (such as vas deferens ligation) or use condoms correctly, or their spouse is required to use hormonal contraceptives approved by the National Medical Products Administration (such as contraceptive pills, patches, implantable or injectable preparations) or intrauterine devices (IUDs) or undergo surgical sterilization; Female subjects may undergo surgical sterilization (such as tubal ligation) or intrauterine devices (IUDs), or their spouses may use condoms correctly or undergo surgical sterilization. After the trial, female subjects may also use hormone contraceptives approved by the National Medical Products Administration (such as contraceptive pills, patches, implantable or injectable preparations).
Who cannot join
- History of drug allergy or allergic related diseases (allergic rhinitis, asthma, urticaria, eczema, etc.)，allergic to experimental drugs and excipients or GLP-1 class drugs.
- Significant history or clinical manifestation of any neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune or skeletal, as determined by the Investigator.
- Family or personal history of medullary thyroid carcinoma (MTC).
- Medical history of multiple endocrine neoplasia type 2(MEN2).
- History of acute or chronic pancreatitis.
- History of hypoglycemia.
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- Calcitonin equal or above 50 ng/L at screening.
- The content of amylase or lipase during the screening period is higher than the upper limit of normal values and has clinical significance.
- Screening period HbAlc (glycated hemoglobin) ≥ 6.5%.
- According to the Fridericias formula，QTcF ≥ 450 ms for subjects in 12-lead ECG examination during screening or baseline period.
- History of drug abuse within the previous year of screening or positive results from drug abuse screening (urine screening).
- Have smoked ≥5 cigarettes per day in the past 3 month prior to Screening or unable to refrain from smoking during the study.
- Screening for subjects who have consumed more than 14 units of alcohol per week within the first 3 months (1 unit of alcohol=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine), or who have taken alcoholic products within 48 hours before administration, or who cannot abstain from alcohol during the trial period.
- Positive test for hepatitis B surface antigen (HBsAg)，hepatitis C antibody (HCV-Ab), human immunodeficiency virus (HIV-Ab) antibody, treponema pallidum(TP-Ab) antibody at screening.
- Screening for subjects who have participated in other clinical trials and received drug therapy or medical device intervention within the first 3 months.
- Blood donation or blood loss - more than 400 mL during the 3 months prior to screening, or received blood transfusion; or blood donation or blood loss - more than 200 mL during the 1 months prior to screening.
- History of infectious diseases within 4 weeks before screening (judged by the investigator to affect the ability of the subject to participate in the test)
- Cannot tolerate venous puncture blood collection or have a history of fainting or fainting
- Received vaccination within 28 days prior to administration or plan to receive vaccination during the study period.
- Use of prescription or non-prescription or chinese herbal medicine or discontinue medication before 1 month to screening or within 5 half-lives of the medicinal product, (whichever is longest).
- Participant is unable to refrain from strenuous exercise during the study
- Breastfeeding or pregnant women, or positive tests of pregnancy in screening or baseline
- Other unsuitable conditions to participate in the clinical study judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Parallel Assignment, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of ZT002 in Healthy Participants
This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ZT002, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZT002Drug
Participants will receive a single subcutaneous (SC) ZT002 injection.
PlaceboOther
Participants will receive same volume as of the study drug.
| Study group | Role | What they receive |
|---|---|---|
| ZT002 | Experimental | Participants will be randomized to receive ZT002 injection or Placebo in 1 of 6 dose cohorts. Receives: Drug: ZT002 |
| Placebo | Placebo comparator | Participants will be randomized to receive ZT002 injection or Placebo in 1 of 6 dose cohorts. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a single escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in SAD Cohorts. Number of participants with treatment-emergent adverse events
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Up to 50 days
Safety and tolerability of a single escalation dose of ZT002 through the incidence severity of serious adverse events in SAD Cohorts. Number of participants with serious adverse events.
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Up to 50 days
Secondary outcomes (3)
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD Cohorts.
Parameter: Maximum observed plasma concentration of ZT002 (Cmax)
Measured: Up to 50 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD Cohorts.
Parameter: Area under the drug-time curve from 0 h after dosing to the last quantifiable concentration time point (AUC0-last)
Measured: Up to 50 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD cohorts.
Parameter: Area under the drug-time curve to infinity (AUC0-inf)
Measured: Up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start19 Jun 2023
- Primary completion20 Oct 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Hospital
- Responsible party
- Sponsor
- Investigators
- Aixin Shi, Master, Principal investigator, No.1 Dahua Road, Dongdan, Dongcheng District, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423872
- Sponsor's protocol ID
- BJQLZT002002
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Parallel Assignment, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of ZT002 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06423872
- Acronym / sponsor ID
- BJQLZT002002
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Hospital
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZT002 | Experimental | Drug: ZT002Participants will be randomized to receive ZT002 injection or Placebo in 1 of 6 dose cohorts. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be randomized to receive ZT002 injection or Placebo in 1 of 6 dose cohorts. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fully understand the purpose, nature, methods, and potential adverse reactions of the experiment, voluntarily participate as a participant, comply with the requirements of this study, and sign an informed consent form.
- Healthy adults, age 18~45 years, both inclusive, at time of informed consent.
- Body Mass Index (BMI) between 19～27.0 kg/m2 both included. Male weight>55.0kg, famale weight>50.0kg.
- In good health, determined by no clinically significant findings from medical history, physical examination, vital signs measurements, anterior and lateral chest X-ray,12-lead ECG, and clinical laboratory evaluations(blood routine, blood biochemistry, coagulation function, and urine routine)at screening and before administration of study drug, as assessed by the Investigator.
- Female participants are required to abstain or use two effective contraceptive methods simultaneously from 1 month before screening to 6 months after the last dose. Male participants are required to abstain or use two effective contraceptive methods simultaneously from the first dose to 6 months after the last dose: male participants are required to undergo surgical sterilization (such as vas deferens ligation) or use condoms correctly, or their spouse is required to use hormonal contraceptives approved by the National Medical Products Administration (such as contraceptive pills, patches, implantable or injectable preparations) or intrauterine devices (IUDs) or undergo surgical sterilization; Female subjects may undergo surgical sterilization (such as tubal ligation) or intrauterine devices (IUDs), or their spouses may use condoms correctly or undergo surgical sterilization. After the trial, female subjects may also use hormone contraceptives approved by the National Medical Products Administration (such as contraceptive pills, patches, implantable or injectable preparations).
Key exclusion criteria (23 listed)
- History of drug allergy or allergic related diseases (allergic rhinitis, asthma, urticaria, eczema, etc.)，allergic to experimental drugs and excipients or GLP-1 class drugs.
- Significant history or clinical manifestation of any neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune or skeletal, as determined by the Investigator.
- Family or personal history of medullary thyroid carcinoma (MTC).
- Medical history of multiple endocrine neoplasia type 2(MEN2).
- History of acute or chronic pancreatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZT002Participants will receive a single subcutaneous (SC) ZT002 injection. | Drug | ZT002 |
| PlaceboParticipants will receive same volume as of the study drug. | Other | Placebo |
Primary outcome
Safety and tolerability of a single escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in SAD Cohorts. Number of participants with treatment-emergent adverse events
Time frame: Up to 50 days
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Safety and tolerability of a single escalation dose of ZT002 through the incidence severity of serious adverse events in SAD Cohorts. Number of participants with serious adverse events.
Time frame: Up to 50 days
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
3 secondary outcomes
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD Cohorts.
Time frame: Up to 50 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD Cohorts.
Time frame: Up to 50 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD cohorts.
Time frame: Up to 50 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aixin Shi, Master principal investigator
No.1 Dahua Road, Dongdan, Dongcheng District, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZT002 in people with Type 2 Diabetes Mellitus, run by Beijing QL Biopharmaceutical Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of a single escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in SAD Cohorts. Number of participants with treatment-emergent adverse events (time frame: Up to 50 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.